Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health (BSS)

February 26, 2021 updated by: Janet Rich-Edwards, Brigham and Women's Hospital
This intervention study will address the impact of vitamin D fortified milk and vitamin D supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone, academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for eczema) of Mongolian children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

597

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children in 3rd and 4th grade from selected Mongolian schools.

  • School selection will consider:

    • socioeconomic position;
    • geographic location;
    • school size;
    • current lunch or supplementation program; and
    • the interest and willingness to participate of the school's administration and faculty.

Exclusion Criteria:

  • Allergy to milk or wheat products.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Mongolian milk without D
Dietary supplement: Mongolian milk without vitamin D
710ml per day for 49 days
Other Names:
  • Guum milk
Experimental: 2
Mongolian milk with vitamin D
Dietary supplement: Mongolian milk with vitamin D
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
Other Names:
  • Guum milk
Experimental: 3
Ultra High Temperature (UHT) milk
Dietary supplement: UHT milk
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
Other Names:
  • Gossner milk
Experimental: 4
Milk Substitute
Dietary supplement: Milk Substitute
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
Other Names:
  • Mead Johnson
Experimental: 5
Seasonal D
Dietary supplement: Seasonal D supplement
Deliver dosage of 13,700 IU vitamin D over 7 days
Other Names:
  • Tish Con
Experimental: 6
Daily D
Dietary supplement: Daily D supplement
Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
Other Names:
  • Tish Con

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
Time Frame: Blood was analyzed at day 0 and day 49
Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry
Blood was analyzed at day 0 and day 49

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Janet Rich-Edwards, Sc.D., Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (Estimate)

April 22, 2009

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSS-103306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin d Deficiency

Clinical Trials on Mongolian milk without vitamin D

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe